Handling:OtherIngredients

National Organic Standards Board

Handling Subcommittee

"Other Ingredients" Discussion Document

August 21, 2012

Introduction1

On Nov. 23, 2011, National Organic Program (NOP) Deputy Administrator Miles McEvoy 

sent a Memorandum to the National Organic Standards Board (NOSB) requesting 

clarification of “other ingredients” contained within handling materials on the National List of 

Allowed and Prohibited substance used in processed organic products. Since OFPA 

requires that each non-organic ingredient be specifically allowed, and because the National 

List does not specifically list “other ingredients” commonly found in formulated products, the 

NOP identified the need for clarity and requested that the NOSB develop a policy that 

specifies whether these “other ingredients” are allowed.

In the memo to NOSB, NOP requested the following:

The NOP is requesting that the NOSB develop a policy on “other ingredients” in § 

205.605 substances that is comparable to the comprehensive policy for crop and 

livestock materials. From this point forward, NOP is requesting that NOSB consider the 

presence of any “other ingredients” as part of its processes. As substances on the 

National List come up for sunset review, or as new petitions are considered, NOP 

requests that NOSB clarify whether any restrictions are warranted for “other ingredients” 

in § 205.605 substances. Any third-party technical report that NOP provides will include 

information on any “other ingredients” commonly found in the substance under review.

NOP is requesting that NOSB specify any allowed “other ingredients” in the background 

section of its recommendations for substances recommended for listing on § 205.605, 

so that these allowances are clear to the organic trade, certifying agents, and NOP. Any 

“other ingredients” not listed on § 205.605 or not referenced in the background section 

of the recommendation, would not be allowed in formulations of substances on § 

205.605 that are used in or on processed products labeled as “organic” or “made with 

organic (specified ingredients or food group(s)).”

The memo continues:

NOSB may want to address the subject further in the future with a comprehensive policy 

for “other ingredients” that may be included in permitted handling materials. Some 

questions that could be addressed in a future recommendation could include the 

following:

1. Should all agricultural ingredients that are “other ingredients” be organically 

produced?

2. Are synthetic preservatives allowed as “other ingredients?

In response to the memo, the NOSB Handling Sub-Committee is currently working to 

develop a policy for “other ingredients” that may be included in permitted handling materials. 

This discussion document defines “other ingredients” and the scope of their review, 

 1 The NOSB Handling Subcommittee wishes to thank the members of the ad hoc Materials Working Group for providing a framework 

for this Discussion Document. Their names are in Appendix 3.
Handling:OtherIngredients

provides historical and regulatory background, and proposes a range of policy options for 

consideration along with an assessment of their impact on the organic sector.

Background 

The NOP regulations require that all certified organic producers and handlers use materials 

that comply with the applicable parts of the Standards [7 CFR Part 205]. The Standards 

include Subpart G (The National List), which dictates allowed synthetic and prohibited 

nonsynthetic inputs for use in organic crop and livestock production and nonorganic 

substances allowed in organic food processing and handling. 

In general, for crop and livestock production, non-synthetic materials are allowed unless 

prohibited. Synthetic substances may be used provided they are on the National List and 

used in accordance with any specified restrictions. In contrast, the handling standards 

require that all non-organic non-agricultural substances, whether synthetic or non-synthetic, 

be included on the National List. Non-organic agricultural ingredients used in the 5% of an 

“organic” product must also be on the National List AND commercially unavailable in 

organic form.

Some items on § 205.605 and on § 205.606, however, are sold as multicomponent 

substances or mixtures wherein the “active” or listed substance is combined with “other 

ingredients,” (e.g. carriers, stabilizers and antioxidants) to provide a necessary technical 

effect on the National List substance. In certain cases, small amounts of standardizing 

agents may be incorporated to ensure the substance meets the specifications required by 

their standards of identity. Examples of § 205.605 substances that generally contain “other 

ingredients” include, but are not limited to, biological substances such as enzymes, dairy 

cultures and microorganisms; cleaners, sanitizers and disinfectants such as peracetic acid; 

and nutrient vitamins. Examples of § 205.606 items that generally contain “other 

ingredients” include, but are not limited to, casings from processed intestines, colors, fish 

oil, pectin, and whey protein concentrate.

The chart in Appendix 4 lists the substances currently on §205.605, the specific list of nonagricultural substances that are the subject of the NOP request; the agricultural substances 

currently listed at §205.606, which were not mentioned in the NOP request but some of 

which share the characteristic of containing “other ingredients”; and those substances 

recommended by NOSB but which have not yet completed the process, along with those 

“other ingredients” identified in the original petition, a Technical Advisory Panel (TAP)

review or a Technical Report (T)R). The chart also references examples of “other 

ingredients” that are disclosed on specification sheets that certifiers use when determining 

compliance for a formulated ingredient.

Currently, the allowance of “other ingredients” in substances on the National List used in 

processed organic products is unclear, particularly in contrast with crop and livestock 

substances. For organic crop and livestock production, specific categories of “other 

ingredients” are allowed as inert ingredients in pesticides and excipients in animal drugs. 

While inert ingredients used in pesticide products, and excipients used in animal drugs are 

addressed, the regulations are silent on “other ingredients” used in non-pesticide and nondrug products. As stated in the NOP memo of November 23, 2011, for crop and livestock 
Handling:OtherIngredients

products, a synthetic “other ingredient” is prohibited unless it appears on the National List 

and non-synthetic “other ingredients” are allowed unless prohibited by the National List. 

The Handling Subcommittee believes that exceptions have been made for livestock 

vitamins and minerals due to the fact that they commonly contain “other ingredients” but 

their use is required to fulfill the nutritional needs of certified livestock.

In contrast, the National List for processed products does not include a provision that 

provides allowances for any “other ingredients”. Instead, certain substances on the National 

List, such as flavors, colors and fish oil, specify a restriction on the use of “other 

ingredients.” This has led some to believe that “other ingredients” used in handling 

materials are allowed unless specifically prohibited. 

Relevant areas in OFPA and Regulations (see Appendix 1 for full references)

OFPA prohibits a certified handler from adding “any synthetic ingredient not appearing on 

the National List during processing or any postharvest handling.” The National List heading 

in the regulations at § 205.605 and § 205.606 also specify the use of non-agricultural 

substances and agricultural products, respectively, referred to as ‘ingredients.’ While 

OFPA does not reference processing aids, the regulations under § 205.301(f)(4) prohibit 

the use of ‘processing aids’ during the handling of an organic product unless they are 

approved on the National List. Both terms are included under 205.2 (Terms Defined). 

Furthermore, in the final ruling on the Harvey II case the Courts determined that Congress 

did not distinguish between the general term “ingredients” and “processing aids,” and 

authorized the use of synthetic substances, whether ingredients or processing aids, for the 

use in handling operations so long as they appear on the National List.

2

.

The Federal Rule § 205.301 determines that product composition for products labeled as 

"organic" must contain only ingredients that are organically produced (95%) or "be 

nonagricultural substances or nonorganically produced agricultural products produced 

consistent with the National List in subpart G of this part".

Examples of specified restrictions addressing "other ingredients" in § 205.605 include:

Flavors, nonsynthetic sources only and must not be produced using synthetic 

solvents and carrier systems or any artificial preservative.

Peracetic acid/Peroxyacetic acid (CAS # 79–21–0)—for use in wash and/or rinse 

water according to FDA limitations. For use as a sanitizer on food contact surfaces.

Examples of specified restrictions addressing "other ingredients" in § 205.606 include:

(d) Colors derived from agricultural products—Must not be produced using synthetic 

solvents and carrier systems or any artificial preservative.

 2

OFPA does not refer to ‘processing aids.’ However, in the final ruling on the Harvey II case Nov. 2, 2006, the District Court of 

Maine ruled that the OFPA change of 2005 that allowed synthetic “ingredients” also allowed synthetic “processing aids” as long as 

they appear on the National List. The Court determined that Congress did not distinguish between the general term “ingredients” and 

“processing aids,” and authorized the use of synthetic substances, whether ingredients or processing aids, for the use in handling 

operations so long as they appear on the National List (Memorandum Decision on Motion to Enforce Judgment and Cross Motion for 

Relief from Judgment, U.S. District Court, District of Maine, Civil Docket 2:02cv216).
Handling:OtherIngredients

(f) Fish oil (Fatty acid CAS #'s: 10417–94–4, and 25167–62–8)—stabilized with 

organic ingredients or only with ingredients on the National List, §§205.605 and 

205.606.

The inconsistent use of the term ‘substance’ used throughout OFPA and the regulations, 

and the Federal Register Notice on Procedures for Submitting National List Petitions [72 

Federal Register 2167] has not fostered a clear and consistent approach to the issue. The 

Notice reads:

Any person may submit a petition requesting a substance to be reviewed by the NOP 

and NOSB at any time. Each substance to be evaluated for the National List must be 

submitted in a separate petition. Only single substances may be petitioned 

for evaluation; formulated products cannot appear on the National List.

Discussion

Defining “other ingredients”

This discussion paper focuses on the use and allowance of “other ingredients” contained 

in § 205.605 items. The term “other ingredients,” as described in the NOP Memo to NOSB, 

is not a recognized regulatory term with a legal definition. However since the term was 

used in the NOP Memo, it will be used throughout this discussion document. For this

purpose, “other ingredients” will be defined as additives added during the manufacturing of 

a non-organic substance and not removed. They are defined as “incidental additives” by 

FDA.

FDA defines “incidental additives” as ingredients that are present in a food at insignificant 

levels and do not have any technical or functional effect in that food. An incidental additive 

is usually present because it is an ingredient within another ingredient used in the final 

product, or it is a processing aid added to a food for its technical or functional effect in the 

processing and present only in insignificant amounts in the final food. In such cases, per 

FDA labeling regulations, incidental additives and processing aids do not need to be 

declared on the label of the final food (certified product) (CFR Title 21 101.22(h)(3) and 

101.100 (a)(3i to iii4). See Appendix 2 for other relevant FDA Definitions.

It should be clear that “other ingredients” discussed in this paper are not the same as 

“ingredients” or “processing aids” used for a specific purpose directly by a certified handler 

in or on processed organic products. The regulations are clear that non-organic 

‘ingredients’ or ‘processing aids’ used directly by a certified handler in or on a certified 

organic processed product must be on the National List at § 205.605 or § 205.606. “Other 

ingredients” are substances that are present by way of having been incorporated into an 

allowed substance on the National List. As such, most, if not all “other ingredients,” will fall 

under FDA’s definitions for incidental additives and, if present at only insignificant levels, 

are exempt from FDA’s labeling requirements. 

The NOP memo only requested a policy on § 205.605 listings on the National List. 

However non-organic agricultural ingredients or products listed on § 205.606 of the 

National List often contain "other ingredients" also. The Handling Sub-Committee believes 

it will be more efficient and result in overall better comprehension to address both sections 
Handling:OtherIngredients

of the National List at the same time. Therefore, we have incorporated § 205.606 into our 

policy options in this discussion paper.

We have not presented policy options for synthetic solvents and processing aids used 

during the production of non-organic ingredients on § 205.605 and § 205.606 in this 

document. This topic is part of the overall ‘Classification of Materials’ discussion, thus we 

believe it is outside the scope of the “other ingredients” discussion provided the processing 

aids or solvents undergo a removal step. 

Baseline Criteria 

We believe that baseline criteria that should be used for the evaluation of “other 

ingredients,” based on the existing requirements that are already imposed by OFPA and 7 

CFR Part 205. This would parallel those identified in the NOP Memo for Inerts in crop 

pesticides and Excipients in Livestock drugs. These baseline criteria would apply to all 

policy options for review of ingredients.

The baseline criteria are as follows:

“Other ingredients” are those that are authorized for use in materials on the National List at 

§ 205.605 and § 205.606 according to the following criteria:

1. The National List [7 CFR 205.605 – 606] or;

2. Mandatory federal requirements [7 U.S.C. §6519(f)] or;

3. FDA (GRAS) or otherwise [7 U.S.C. § 6517(c) and 7 U.S.C 6519(f)]; or

4. EPA [7 U.S.C. § 6517(c) and 7 U.S.C 6519(f)] or;

5. Any other federal regulatory agency with primary jurisdiction over that substance [7 

U.S.C 6519(f)].

AND any component or ingredient would be disallowed if:

6. Prohibited by federal regulatory action [7 U.S.C. § 6517(d)] or;

7. Produced using excluded methods [7 CFR 205.105(e) and 7 CFR 205.2] or;

8. Contain any heavy metals or toxic residues in excess of established tolerance levels 

set by FDA or EPA [7 U.S.C. § 6510(a)] or;

9. It provides a technical or functional effect in the final certified organic product and 

therefore does not meet FDA’s definition of an ‘incidental additive’.

Policy Options

NOSB currently evaluates materials on a case-by-case basis without an overarching policy 

for “other ingredients.” Additionally, ACAs and MROs have no overall guidance on other 

ingredients from the NOP, varying capacities for materials review and wide latitude to make 

decisions unless specific decisions are overruled by the NOP. While the review of materials 

in general for use in organic production and handling is currently quite rigorous, there is 

need for improvement and harmonization of the system to assure continued confidence 

and growth of the industry. 

NOP clearly recognizes the need to improve review of non-organic ingredients as reflected 

by their declaration in the memo that third party technical reports will include information on 

“other ingredients” and their request that NOSB consider their presence as part of their 

review process “from this point forward.” In acknowledgement of this request, the options 
Handling:OtherIngredients

presented all include NOSB review of “other ingredients”. A fundamental variation between 

the options however is the method by which NOSB specifies the allowance of “other 

ingredients” after they have conducted their review. 

Option A simply includes NOSB review of “other ingredients” as requested by NOP, but 

allows for the presence of all “other ingredients” unless they are restricted or prohibited by 

an annotation. Option B aligns with the request in the NOP memo, but includes suggestions 

to help facilitate review by certifiers and MROs and includes additional criteria that are 

specific to the various categories of materials on § 205.605 and § 205.606. Option C 

presents a blanket policy that while easy to understand would be very challenging to 

implement. The pros and cons of each option are described in further detail below.

Option A 

For all newly petitioned non-organic ingredients, the NOSB considers "other ingredients" 

identified in the petition and Technical Report and documents the review in the background 

section of their recommendation. Items already on the National List are not subject to this 

provision, unless the NOSB explicitly requests a Technical Report to address the ‘other 

ingredient’ question of a particular item subject to Sunset Review. Unless restrictions are 

specified in an annotation, any “other ingredient” that meets Baseline Criteria is permitted.

Review Criteria for NOSB

Other ingredients must meet Baseline Criteria (above). NOSB will determine whether 

any specific prohibitions that should be specified in an annotation based on their review 

of “other ingredients” discussed or disclosed in the petition or Technical Report or 

presented in further research or public comment. 

Pros:

• Processors, handlers and their suppliers have the greatest possible latitude to 

formulate ingredients and develop organic products.

• ACAs and MROs have a minimum amount of documentation to review.

• All products that meet the current standard and policy comply unless NOP specifies 

otherwise.

• Policy is the least likely to cause inconsistencies with major trading partners. 

• Greater number of options for non-organic ingredients.

• Less time and energy spent on the allowed non-organic portion freeing up more time 

to advocate and work towards increased organic production.

Cons:

• Little incentive to source organic alternatives to ingredients on 7 CFR 205.605.

• There is no transparent way to be able to look up all of the non-organic substances 

that might be contained in a certified product containing non-organic ingredients.

• Potential decline in the value of the organic label due to dilution and loss of 

consumer confidence.

Option B 

The NOSB would follow the request by NOP to consider “other ingredients” during their 

review as substances come up for sunset review or as new petitions are considered. The 

NOSB would review “other ingredients” included in the petition and Technical Report. The 
Handling:OtherIngredients

NOSB recommendation includes a note that the other ingredients were reviewed and 

accepted. The “other ingredient” is entered into a database maintained on the NOP 

Website. Materials listed on § 205.605(a) and § 205.606 must not contain any "synthetic" 

incidental additives unless they are on the National List at § 205.605(b) or specifically 

allowed by NOSB. Non-synthetic incidental additives are allowed unless specifically 

prohibited. Synthetic incidental additives are allowed in 205.605(b) items if they are 

included and documented in the NOSB review. Any additional restrictions are specified in 

an annotation. 

Other ingredients in general product categories that are currently on § 205.605 and § 

205.606 and currently used in certified organic processed product will be grandfathered for 

one sunset period recommendations, including vitamins, minerals, enzymes, dairy cultures, 

yeast, microorganisms, natural flavors, and colors. NOSB can recommend exceptions for 

new materials that are petitioned as appropriate. The National List is restructured to create 

a separate category and exceptions for cleaners, sanitizers, disinfectants and other 

substances that are secondary direct and indirect food additives subject to a separate 

Baseline Criteria.

Review Criteria for NOSB:

• Other ingredients must meet Baseline Criteria (above). 

• NOSB considers “other ingredients” as disclosed in the petition and Technical 

Report.

• If the substance is recommended for inclusion on the National List, the NOSB 

may specify implicit allowance of all other ingredients, deny allowance of other 

ingredients, or prohibit those other ingredients in the recommendation. 

• NOSB may recommend “other ingredients” individually, categorically or a 

combination of both. 

• Non-synthetic ingredients used as other ingredients in items are allowed unless 

specifically prohibited. 

• The NOSB may stipulate in a review that any agricultural "other ingredients" must 

be organically produced.

• Materials listed on § 205.605(a) and 205.606 must not contain any "synthetic"

incidental additives unless they are on the National List at § 205.605(b) or 

specifically allowed by NOSB.

• Synthetic incidental additives are allowed in 205.605(b) substances if they were 

reviewed, approved and documented by NOSB.

• NOSB specifies any additional restrictions or allowances in an annotation. 

• As a part of the Sunset Review process, the NOSB should request Technical 

Reports on the following product categories currently on the National List: 

o Vitamins/Minerals

o Enzymes (including animal enzymes)

o Microorganisms

o Dairy Cultures 

o Natural Flavors

o Agricultural Colors

The TR will help the NOSB determine whether other ingredients that are not 

“organic” or on the National List are currently being used in these categories and 

whether to recommend annotation or documentation in the database.
Handling:OtherIngredients

• “Other ingredients” contained in sanitizers or cleaners or other similar non-food 

inputs that are used in direct contact with certified product must be on the 

National List or their allowance must be specified through an annotation via a 

CAS number or reference to another agency’s regulation, (e.g. peracetic acid), or 

their use must be mandated by law or specifically allowed through NOP Policy.

• Substances classed by FDA as secondary direct or indirect additives not used in 

direct contact with certified product are allowed provided the operator has clear 

intervention/contamination prevention measures detailed in their OSP.

Pros: 

• Greater consistency amongst ACA’s and MRO’s.

• Having the NOSB provide relevant annotations for each material would enable each 

material to be looked at in its context. 

• The NOSB assessment would be open for review and public comment, bringing 

greater transparency. 

• Would clarify the review process for most materials that contain carriers, stabilizers, 

standardizing agents.

• Most likely to meet many if not most consumer advocates expectations for organic 

food.

• Individual ingredients would be assessed according to use and type.

• Other regulatory agencies would be referred to for legally approved formulas for 

cleaners, sanitizers, boiler additives. 

Cons:

• Annotations can still be interpreted differently and may not always be clear. 

• Annotations are verified through desk audit. Increased paperwork for verification 

purposes.

• This option could only work if there is a consistent policy/decision tree on how to 

determine nonsynthetic vs. synthetic.

• More work for the NOSB.

• More work for ACAs and MROs to collect and review the necessary information.

• Only certain specific formulas will be petitioned and receive Technical Reports.

Some Branded formulations currently used in organic processed products may 

include other ingredients not reviewed because the manufacturer is unable or 

unwilling to disclose all of the ingredients. 

• The NOP may not keep up the aforementioned database

Option C

All ingredients in a processed product labeled as organic must either be organically 

produced or on the National List. NOSB creates three new sections to the National List that 

are designated for incidental additives only (other ingredients). They may not be used 

directly by a certified handler in or on a certified product. They are allowed only by way of 

having been incorporated into a substance appearing on § 205.605 or § 205.606 of the 

National List. 

Review Criteria for NOSB
Handling:OtherIngredients

• Review all petitions for other ingredients according to the Baseline Criteria, the 

regulations and guidance. 

• Review during Sunset the “other ingredients” not previously petitioned or allowed.

• Suspend all new petitions for final ingredients until there are petitions for other 

ingredients. (Or: Require petitioners of final ingredients to submit petitions for other 

ingredients if not previously petitioned or allowed.) 

• NOSB creates three new sections to the National List that are designated for 

incidental additives only (other ingredients). The new sections would be as follows:

o § 205.607(a) Non-synthetic nonagricultural incidental additives allowed only in 

substances that appear on § 205.605(a) or § 205.605(b);

o § 205.607(b) Synthetic nonagricultural incidental additives allowed only in 

substances that appear on § 205.605(b); and

o § 205.607 (c) Non-organic agricultural incidental additives allowed only in 

substances that appear on § 205.605(a), § 205.605(b), or § 205.606.

• Exceptions are made for cleaners, sanitizers, disinfectants and secondary direct 

food additives:

o “Other ingredients” contained in sanitizers or cleaners or other similar nonfood inputs that are used in direct contact with certified product must be on 

the National List or their allowance must be specified through an annotation 

via a CAS number or reference to another agency’s regulation, (e.g. peracetic 

acid), or their use must be mandated by law or specifically allowed through 

NOP Policy.

o Secondary direct or Indirect additives not used in direct contact with certified 

product are allowed provided the operator has clear 

intervention/contamination prevention measures detailed in their OSP.

• NOSB recommends a transition time for currently listed substances that will allow 

manufactures and non-organic ingredients and certified handlers adequate time to 

bring products into compliance. NOP will specify this transition or implementation 

time in their draft and final guidance.

Pros:

• More clarity about the regulation.

• Reduced number of options for non-organic ingredients and corresponding growth of 

organic minor ingredients that would lead to increased organic acreage and 

increased business opportunity. 

• Customers who buy and eat organic foods can be certain that all the incidental 

ingredients, which by law are not required to be listed on the finished product label, 

in an organic product are either organic or on the National List.

• ACAs and MROs have a clear rule to make materials decisions.

• Promotes a strong incentive to use organic ingredients.

• Clear and simple process for retailers and marketers to explain to consumers. 

• Most likely to meet many if not most consumer advocates expectations for organic 

food.

Cons:
Handling:OtherIngredients

• Most restrictive in terms of what ingredients can be used.

• All “other ingredients” (carriers, standardizing agents, stabilizers, pH adjusters, 

diluents, etc.) that are not on the National List or “organic” will need to be petitioned 

which could result in significant review and rulemaking. 

• NOP and NOSB have limited time and resources and could be overly burdened by 

the time needed to review petitions and complete necessary rulemaking. 

• Could potentially increase the number of synthetic substances on the National List, 

which may be misunderstood by consumers.

• Reduced number of options for non-organic ingredients and corresponding loss of 

products currently on the market due to limited options, especially for materials like 

pectin and gums.

• Would have commercial and cost implications for certified manufacturers that could 

lead to loss of organic products, which would lead to reduced organic acreage.

• Many products currently on the market may be non-compliant.

• Product from countries with an equivalency agreement won’t need to comply.

• Product from countries without an equivalency agreement may file a Technical 

Barrier to Trade complaint with the World Trade Organization.

• Would have commercial and cost implications for certified manufacturers

• Similar “cons” related to varying interpretations of annotations and the potential for 

the NOSB to list “other ingredients” that are petitioned by a select few. 

• May result in certified organic products currently on the market becoming 

unavailable because a manufacturer of an ingredient chooses not to reformulate to 

meet these new requirements.

Other Considerations

In the course of developing policy options for this paper, several other considerations 

became apparent. The Handling Sub-Committee hopes to do further work on some of 

these subjects in the future and brings them up here because they are relevant to reviewing 

handling materials under any of these policy options.

• It would be helpful if the NOP creates a publicly available database that documents 

material review and specifies “other ingredients” that were reviewed and approved.

• If a new policy is adopted there will be need for transition time for operators to bring 

products into compliance. NOP will need to specify this transition or implementation 

time in their draft and final guidance.

• We would like to explore a recommendation to move cleaners, sanitizers, disinfectants 

and other non-food substances such as boiler additives to their own designated section 

of the National List and develop policy specific to these types of items.

• We would like to ask NOP to report on what legal and regulatory hurdles exist that 

prevent assigning commercial availability to all § 205.605. If no hurdles exist, we will 

consider drafting a recommendation that would assign commercial availability to all § 

205.605 listed substances.

Increasing the use of organic ingredients and processing aids has been a very explicit goal 

of the organic community since early on. The key to increasing organic ingredients lies in 

the interpretation of the phrase, commercial availability. The NOSB has already endorsed 

the concept of a pro-active approach to the development and creation of organic analogs to 
Handling:OtherIngredients

replace non-organic and synthetic items. Implementation of the pro-active program that 

would apply to both § 205.605 and § 205.606 substances would help encourage and 

further the development of organic minor ingredients. In turn this would likely stimulate the 

use of “other ingredients” in 205.605 substances that are either organic or on the National 

List.

Comments Requested

1. Which is your preferred option? Please answer with the following in mind:

a. Which option best captures the intent of the law?

b. Which option best captures the expectation of the consumer?

c. Which option is best for the growth of the organic industry?

d. Which option will be the most difficult to implement? Describe the obstacles.

2. Do you think that in general, nonsynthetic incidental additives should be allowed 

without further petitioning, review or rulemaking if they meet baseline criteria?

3. Should the use of organic substitutes be required of § 205.605 substances when 

they are commercially available?

4. Should organic preference (synthetic allowed when nonsynthetic is not available; 

nonsynthetic allowed when organic is not available) be assigned to “other 

ingredients”? Is this practical? How would it be enforced?

5. Is it acceptable to allow “other ingredients” as incidental components of an allowed 

substance on the National List? Does it make a difference knowing they are present 

at amounts typically below 10ppm?

6. Should sanitizers, cleaners and disinfectants be moved to their own section of the 

National List and dealt with separately from ingredients and processing aids?

7. Should “other ingredients” used in sanitizers, cleaners, or disinfectants be organic or 

on the National List?

8. How can the system of reviewing non-organic ingredients used in processed organic 

products be improved? 

Sub-Committee Vote

Motion: The Handling Sub-Committee moves to accept this document and present it for full 

board discussion at the Fall 2012 NOSB meeting

Motion by: Zea Sonnabend Second: Tracy Favre

Yes: 7 No: 0 Absent: 0 Abstain: 0 Recuse: 0

Appendix 1 – Regulatory References
Handling:OtherIngredients

OFPA

SEC. 2111. [7 U.S.C. 6510] HANDLING.

(a) IN GENERAL.—For a handling operation to be certified under this title, each person 

on such handling operation shall not, with respect to any agricultural product 

covered by this title—

(1) add any synthetic ingredient not appearing on the National List during the 

processing or any postharvest handling

SEC. 2118. [7 U.S.C. 6517] NATIONAL LIST.

(a) IN GENERAL.—The Secretary shall establish a National List of approved and 

prohibited substances that shall be included in the standards for organic production 

and handling established under this title in order for such products to be sold or 

labeled as organically produced under this title.

(b) CONTENT OF LIST.—The list established under subsection (a) shall contain an 

itemization, by specific use or application, of each synthetic substance permitted 

under subsection (c)(1) or each natural substance prohibited under subsection (c)(2).

NOP Regulations

§ 205.2. Terms Defined.

Ingredient. Any substance used in the preparation of an agricultural product that is still 

present in the final commercial product as consumed.

Processing aid. 

(1) Substance that is added to a food during the processing of such food but is removed 

in some manner from the food before it is packaged in its finished form;

(2) a substance that is added to a food during processing, is converted into constituents 

normally present in the food, and does not significantly increase the amount of the 

constituents naturally found in the food; and

(3) a substance that is added to a food for its technical or functional effect in the 

processing but is present in the finished food at insignificant levels and does not have 

any technical or functional effect in that food.

§ 205.301 Product composition.

(b) Products sold, labeled, or represented as “organic.” A raw or processed agricultural 

product sold, labeled, or represented as “organic” must contain (by weight or fluid 

volume, excluding water and salt) not less than 95 percent organically produced raw or 

processed agricultural products. Any remaining product ingredients must be organically 

produced, unless not commercially available in organic form, or must be nonagricultural 

substances or nonorganically produced agricultural products produced consistent with 

the National List in subpart G of this part. If labeled as organically produced, such 

product must be labeled pursuant to §205.303.

(c) Products sold, labeled, or represented as “made with organic (specified ingredients 

or food group(s)).” Multi-ingredient agricultural product sold, labeled, or represented as 

“made with organic (specified ingredients or food group(s))” must contain (by weight or 
Handling:OtherIngredients

fluid volume, excluding water and salt) at least 70 percent organically produced 

ingredients which are produced and handled pursuant to requirements in subpart C of 

this part. No ingredients may be produced using prohibited practices specified in 

paragraphs (f)(1), (2), and (3) of §205.301. Nonorganic ingredients may be produced 

without regard to paragraphs (f)(4), (5), (6), and (7) of §205.301. If labeled as containing 

organically produced ingredients or food groups, such product must be labeled pursuant 

to §205.304.

(f) All products labeled as “100 percent organic” or “organic” and all ingredients 

identified as “organic” in the ingredient statement of any product must not:

(4) Be processed using processing aids not approved on the National List of Allowed 

and Prohibited Substances in subpart G of this part: Except, That, products labeled 

as “100 percent organic,” if processed, must be processed using organically 

produced processing aids;

§ 205.605 Nonagricultural (nonorganic) substances allowed as ingredients in or on 

processed products labeled as “organic” or “made with organic (specified 

ingredients or food group(s)).”

The following nonagricultural substances may be used as ingredients in or on 

processed products labeled as “organic” or “made with organic (specified ingredients or 

food group(s))” only in accordance with any restrictions specified in this section.

Examples of specified restrictions addressing “other ingredients”:

Flavors, nonsynthetic sources only and must not be produced using synthetic 

solvents and carrier systems or any artificial preservative.

Peracetic acid/Peroxyacetic acid (CAS # 79–21–0)—for use in wash and/or rinse 

water according to FDA limitations. For use as a sanitizer on food contact surfaces.

§ 205.606 Nonorganically produced agricultural products allowed as ingredients in 

or on processed products labeled as “organic.”

Only the following nonorganically produced agricultural products may be used as 

ingredients in or on processed products labeled as “organic,” only in accordance with 

any restrictions specified in this section, and only when the product is not commercially 

available in organic form.

Examples of specified restrictions addressing “other ingredients”:

(d) Colors derived from agricultural products—Must not be produced using synthetic 

solvents and carrier systems or any artificial preservative.

(f) Fish oil (Fatty acid CAS #'s: 10417–94–4, and 25167–62–8)—stabilized with 

organic ingredients or only with ingredients on the National List, §§205.605 and 

205.606.
Handling:OtherIngredients

Appendix 2 – FDA terms 

Food additive. A substance, the intended use of which results or may reasonably be 

expected to result, directly or indirectly, either in the substance becoming a component of 

food or otherwise affecting the characteristics of food. A material used in the production of 

containers and packages is subject to the definition if it may reasonably be expected to 

become a component, or to affect the characteristics, directly or indirectly, of food packed 

in the container. A substance that does not become a component of food, but that is used 

in preparing an ingredient of the food to give a different flavor, texture, or other 

characteristic in the food, may be a food additive. 21 CFR § 170.3.

Secondary Direct Food Additive. This term is in the title of 21 CFR 173, which was 

created during recodification of the food additive regulations in 1977. A secondary direct 

food additive has a technical effect in food during processing but not in the finished food 

(e.g., processing aid). Some secondary direct food additives also meet the definition of a 

food contact substance. For more on food contact substances, consult the Food Contact 

Substance Notification Program.

Indirect Food Additive - In general, these are food additives that come into contact with 

food as part of packaging, holding, or processing, but are not intended to be added directly 

to, become a component, or have a technical effect in or on the food. Indirect food additives 

mentioned in Title 21 of the U.S. Code of Federal Regulations (21CFR) used in foodcontact articles, include adhesives and components of coatings (Part 175), paper and 

paperboard components (Part 176), polymers (Part 177), adjuvants and production aids

and sanitizers (Part 178). Currently, additional indirect food additives are authorized 

through the food contact notification program. In addition, indirect food additives may be 

authorized through 21 CFR 170.39.

Incidental additive. 21 CFR101.100(a)(3) Incidental additives that are present in a food at 

insignificant levels and do not have any technical or functional effect in that food. For the 

purposes of this paragraph (a)(3), incidental additives are:

(i) Substances that have no technical or functional effect but are present in a food by 

reason of having been incorporated into the food as an ingredient of another food, in 

which the substance did have a functional or technical effect.

(ii) Processing aids, which are as follows:

(a) Substances that are added to a food during the processing of such food but are 

removed in some manner from the food before it is packaged in its finished form.

(b) Substances that are added to a food during processing, are converted into 

constituents normally present in the food, and do not significantly increase the amount 

of the constitutents naturally found in the food.

(c) Substances that are added to a food for their technical or functional effect in the 

processing but are present in the finished food at insignificant levels and do not have 

any technical or functional effect in that food.

(iii) Substances migrating to food from equipment or packaging or otherwise affecting food 

that are not food additives as defined in section 201(s) of the act; or if they are food 

additives as so defined, they are used in conformity with regulations established pursuant 

to section 4.
Handling:OtherIngredients

GRAS - "GRAS" is an acronym for the phrase Generally Recognized As Safe. Under 

sections 201(s) and 409 of the FD&C Act, any substance that is intentionally added to food 

is a food additive, that is subject to premarket review and approval by FDA, unless the 

substance is generally recognized, among qualified experts, as having been adequately 

shown to be safe under the conditions of its intended use, or unless the use of the 

substance is otherwise excluded from the definition of a food additive. GRAS substances 

are distinguished from food additives by the type of information that supports the GRAS 

determination, that it is publicly available and generally accepted by the scientific 

community, but should be the same quantity and quality of information that would support 

the safety of a food additive. Additional information on GRAS can be found on the GRAS 

Notification Program page.

Appendix 3 – Materials Working Group

The Materials Working Group is an unaffiliated ad hoc committee of volunteers with 

technical and regulatory background. The MWG was initiated in November, 2007 following 

the NOSB meeting to work on clarifying the issues surrounding the definitions of 

“nonagricultural,” “synthetic” and “nonsynthetic,” and to provide the NOSB with 

recommendations and guidance documents relating to those definitions. Participation in the 

group is voluntary, open and available to any interested party.

The NOSB Handling Subcommittee wishes to thank members of the Materials Working 

Group for their help in putting together this Discussion Document.

Gwendolyn Wyard – Co-facilitator Kim Dietz – Co-facilitator

Brian Baker Johanna Mirenda

Harriet Behar Mary Mulry

Andrea Caroe Tony Pavel 

Katherine DiMatteo Richard Siegel

Lindsay Fernandez-Salvador Zea Sonnabend

John Foster Richard Theuer

Grace Gershuny Gay Timmons 

Daniel Giacomini Jessica Walden 

Katrina Heinze Julie Weisman 

George Kalogridis Darryl Williams

Nate Lewis

Appendix 4 – Chart of § 205.605 and § 205.606 substances along with “other ingredients” 

identified in Technical Reviews and Petitions.

FDA 

Regulatory 

citation & 

Category

7 CFR 205.605 Other Ingredients (TAP, TR, 

Petition, NOSB Recommendation)

Comments

(a) Nonsynthetics allowed: 

Biological Materials
Handling:OtherIngredients

Animal 

enzymes—

(Rennet—

animals 

derived; 

Catalase—

bovine liver; 

Animal lipase; 

Pancreatin; 

Pepsin; and 

Trypsin)

2000 TAP: Enzyme preparations 

usually contain diluents, preservatives 

(to prevent microbial growth In liquid 

preparations), antioxidants, and other 

food grade substances consistent with 

current good manufacturing practice. 

Among the substances used in 

commercial rennet preparations 

include salt (sodium chloride), 

propylene glycol, sodium benzoate, 

and sodium propionate.

21 CFR 

184.1685

Rennet

21 CFR 

184.1034

Catalase

21 CFR 

184.1415

Animal lipase

21 CFR 

184.1583

Pancreatin

21 CFR 

184.1595

Pepsin

21 CFR 

184.1914

Trypsin

21 CFR 

184.

Dairy cultures. No mention of "other ingredients" 

(other than milk)

See 

specification 

sheets for 

Enzymes and 

Dairy Cultures

21 CFR 

184.

Enzymes—must 

be derived from 

edible, nontoxic 

plants, 

nonpathogenic 

fungi, or 

nonpathogenic 

bacteria.

See 

specification 

sheets for 

Enzymes and 

Dairy Cultures

Plant enzymes 1995 TAP: ". . . Carriers and 

stabilizers used to keep them moldfree and stable . . ."

Microbial 

enzymes

1995 TAP: "Preparations from 

microbial sources are the most 

important source of commercial 

enzymes and are produced from the 

fermentation of specifically selected 

nonpathogenic and nontoxicogenic 

strains of microorganisms. These 

microorganisms are grown on 

natural food grade substances 

(such as starch and corn meal) 

Specification 

sheets lists 

calcium sulfate 

and wheat 

(carrier) as 

ingredients 

used in 

combination 

with enzymes. 

See spec sheet 
Handling:OtherIngredients

under controlled conditions which 

prevent the introduction of undesirable 

microorganisms or other substances. 

Enzymes are recovered from the 

fermentation broth under mild 

conditions usually by mechanical 

separation means, such as filtration or 

centrifugation and then concentrated 

using ultrafiltration or evaporation. 

Any carriers, diluents, or 

processing aids used in the 

production of enzyme preparations 

are acceptable for general use in 

food, and the levels used do not 

exceed specified limits." 

"Preservatives are almost always 

added during processing, and 

optionally in the final preparation, to 

prevent microbial growth and to 

stabilize and maintain the desired 

enzymic activity. Proper and 

appropriate use of preservatives and 

stabilizers serve to protect the

consumer from unsafe or ineffective 

enzyme products. When the enzyme 

is intended for addition to food, all 

such additives and diluents must be 

acceptable to the FDA for use in food. 

They must be of food grade quality 

and the levels used must not exceed 

specified limits.” 2011 Enzymes TR: 

"Microbial enzymes used in food 

processing and are typically sold as 

enzyme preparations, which are 

mixtures with the desired enzyme 

activity that contain preservatives 

(such as boric acid and natamycin), 

stabilizers (such as salts and 

aminoacetic acid), and other 

metabolites of the production strain." 

"Substances used in commercial 

rennet preparations include salt 

(sodium chloride), propylene glycol, 

sodium benzoate, boric acid, and 

sodium propionate."

for Watson 

Enzymes. 

Example spec 

sheet for 

Marzyme 

Enzyme lists 

Sodium 

chloride, acetic 

acid and 

sodium acetate

Microorganisms

—any food 

grade bacteria, 

fungi, and other 

TAP: Only discusses enzymes, dairy 

cultures, and yeasts; PETITION: Miso 

- non-pathogenic fungi used for 

fermentation; Pre-gelatinized starch 
Handling:OtherIngredients

microorganism. added. 

21 CFR 

184.

Yeast—

nonsynthetic, 

growth on 

petrochemical 

substrate and 

sulfite waste 

liquor is 

prohibited 

Yeast, Autolysate, Brewer's, 

Nutritional - nothing added 

Yeast, Bakers - Yeast cake is mixed 

with oils, emulsifiers and water... 

(From TAP 1996) Yeast, Smoked -

Hickory smoke added for flavor. Spec 

sheet included with TAP (1996) 

showing only yeast and Hickory 

smoke flavor.

(Autolysate; 

Bakers; 

Brewers; 

Nutritional; 

and Smoked—

non-synthetic 

smoke 

flavoring 

process must 

be 

documented)

Defined Substances

Acids (Alginic; 

Citric—produced 

by microbial 

fermentation of 

carbohydrate 

substances; and 

Lactic).

no "other ingredients"

21 CFR 

184.1011

Alginic acid no "other ingredients"

21 CFR 

184.1033

Citric acid 1995 TAP: "pure substance"

21 CFR

184.1061

Lactic acid TAP: NO additives noted; MSDS 

Indicates impurities in mfg proess 

possible (10-20% Lactic Acid lactate)

21 CFR 

184.1115

Agar-agar. 1995 TAP: no "other ingredients." 

2011 TR: no "other Ingredients."

21 CFR 

184.1155

Bentonite. 1995 TAP: no "other ingredients."

21 CFR 

184.1191

Calcium 

carbonate.

no "other ingredients"

21 CFR 

184.1193

Calcium chloride. No TAP; no "other ingredients"

21 CFR 

184.1230

Calcium 

sulfate—mined.

2001 TAP: Terra Alba as mined may 

contain certain impurities (limestone 

(calcium carbonate) and various 

naturally occurring forms of silica). No 

"added ingredients."
Handling:OtherIngredients

21 CFR 

172.620

Carrageenan. 1995 TAP: Carrageenan precipitated 

isopropyl alcohol may contain traces 

of residual isopropyl alcohol (21 CFR 

refers only to water extraction); may 

contain residues of epichlorhydrin 

from chlorinated antimicrobials. If 

recovered by drum drying, may 

contain up to mono- and diglycerides 

or up to 5% polysorbate 80. 

Chemicals may be added when 

standardizing carrageenan: sugar, 

sodium chloride, potassium chloride, 

phosphate salts, other hydro-colloids. 

2011 TER: No mention of "added 

ingredients."

Example 

Specification 

sheet: 

Standardized 

with Sucrose

21 CFR ??? 

GRAS

Diatomaceous 

earth—food 

filtering aid only.

Some DE is calcined in the presence 

of suitable flux (soda ash (sodium 

carbonate) or other alkaline salt)

21 CFR ??? 

GRAS

Egg white 

lysozyme (CAS # 

9001–63–2)

No specific combination products 

were identified for egg white lysozyme 

(or bromelain). Lysozyme is directly 

added to foods as a hydrochloride 

salt.

21 CFR 

184.

Flavors, 

nonsynthetic 

sources only 

and must not be 

produced using 

synthetic 

solvents and 

carrier systems 

or any artificial 

preservative.

The natural flavor does not contain 

propylene glycol, any artificial 

preservative, and is not extracted with 

hexane. Manufacturers must provide 

written documentation in their Organic 

Handling Plan, which shows that 

efforts were made toward the ultimate 

production of an organic natural flavor 

as listed in the stepwise progression 

below:

1. Natural flavor constituents and nonsynthetic carrier base and 

preservative agents;

2. Organic flavor constituents, organic 

carrier base, and organic preservative 

agents; and

3. Organic flavor constituents 

extracted using organically produced 

solvent, organic carrier base, and 

organic preservative agents.

21 CFR 

172.665

Gellan gum 

(CAS # 71010–

52–1)—high-acyl 

form only.

None shown in TAP, committee 

recommendation or petition

21 CFR 

184.1318

Glucono deltalactone—None shown inTAP. No committee 

recommendation. MSDS shows 99% 
Handling:OtherIngredients

production by the 

oxidation of Dglucose with 

bromine water is 

prohibited.

GDL in petition.

21 CFR 

186.1256

Kaolin. TAP MSDS shows 90-100% kaolin. 

No petition, or recommendations 

given

21 CFR 

184.1069

L-Malic acid 

(CAS # 97–67–

6).

TAP: No other ingredients identified; 

must be from microbial fermentation. 

21 CFR 

184.1443

Magnesium 

sulfate, 

nonsynthetic 

sources only.

TR: No other ingredients

21 CFR 

184.1540

Nitrogen—oilfree grades.No other Ingredients 

21 CFR ??? 

GRAS

Oxygen—oil-free 

grades.

No other Ingredients 

21 CFR ??? 

GRAS

Perlite—for use 

only as a filter 

aid in food 

processing.

No other Ingredients 

21 CFR 

184.1622

Potassium 

chloride.

No documents available on NOP 

website

21 CFR 

184.1634

Potassium 

iodide.

No other Ingredients 

21 CFR 

184.1736

Sodium 

bicarbonate.

1995 TAP: No combinations listed. 

One reviewer states: "As with all 

synthetic inorganic salts, source must 

be food grade. In addition each lot 

should be analyzed for toxic element 

concentrations (mercury, lead, 

cadmium, arsenic, thallium and 

antimony) and a near zero tolerance 

adopted.

21 CFR 

184.1742

Sodium 

carbonate.

1995 TAP: No combinations listed. 

One reviewer states: "As with all 

synthetic inorganic salts, source must 

be food grade. In addition each lot 

should be analyzed for toxic element 

concentrations (mercury, lead, 

cadmium, arsenic, thallium and 

antimony) and a near zero tolerance 

adopted.

21 CFR 

184.1099

Tartaric acid—

made from grape 

wine.

1995 TAP: 
Handling:OtherIngredients

Waxes—

nonsynthetic 

(Carnauba wax; 

and Wood resin).

Wax 2007 TAP: "Shellac is used as a 

hard protective coat, and will rapidly 

harden if not kept in a solvent. 

Aqueous lac will also be combined 

with various synthetic preservatives 

such as phenol, or the mixed methyl 

and propyl esters of p-hydroxybenzoic 

acid. It is almost always used with 

pure ethyl alcohol, but will 

occasionally isopropyl alcohol is used 

as a solvent. Often used with wood 

resins. Ammonium soap is used as a 

flowing and solidifying agent with 

wood resin and shellac."

21 CFR 

184.1978

Carnauba wax 1996 TAP ("Fruit Waxes"): No other 

Ingredients 

21 CFR 

172.210

Wood rosin 1996 TAP ("Fruit Waxes"): No other 

Ingredients 

(b) Synthetics allowed: 

Sanitizers, other Secondary 

Direct Food Additives

Sanitizer 

examples and 

common "other 

ingredients" are 

not presented 

here.

21 CFR 

186.1750

Acidified 

sodium 

chlorite—

Secondary 

direct 

antimicrobial 

food treatment 

and indirect 

food contact 

surface 

sanitizing. 

Acidified with 

citric acid only.

21 CFR 

173.325

Chlorine 

materials—

disinfecting and 

sanitizing food 

contact 

surfaces, 

(Calcium 

hypochlorite; 

2006 TR: "products contain no other 

active ingredients and contain no inert 

ingredients other than water"

Except, That, 

residual 

chlorine levels 

in the water 

shall not 

exceed the 

maximum 

residual 
Handling:OtherIngredients

Chlorine 

dioxide; and 

Sodium 

hypochlorite).

disinfectant 

limit under the 

Safe Drinking 

Water Act

21 CFR ??? Calcium 

hypochlorite

21 CFR 

186.1750

Sodium 

hypochlorite

21 CFR 

178.1010

Chlorine dioxide

21 CFR 

184.1366

Hydrogen 

peroxide.

21 CFR 

184.1563

Ozone. Petition includes oxygen and air as 

potential secondary ingredients; no 

other ingredients noted

21 CFR 

178.1010

Peracetic 

acid/Peroxyacet

ic acid (CAS # 

79–21–0)—for 

use in wash 

and/or rinse 

water according 

to FDA 

limitations. For 

use as a 

sanitizer on 

food contact 

surfaces.

Original petition unable to obtain from 

NOP website; TAP Crops and 

Livestock: Stabilizers are 

acknowledged to be not considered in 

the review; TAP Processing: HEDP, 

dipicolini acid (2, 6-

pyridinedicarboxylic acid), sulfuric 

acid, octanoic acid, peroxyoctanoic 

acid, sodium 1-octanesulfonate -

mentioned in TAP but not evaluated to 

OFPA and the NL; HEDP mentioned 

in TAP reviews Committee 

recommendation.

21 CFR 

173.370

Acetic acid

21 CFR 

184.1005

Hydrogen 

peroxide

No TAP, committee recommendation, 

or petition shown. 

21 CFR 

184.1366

HEDP (1-

hydroxyethyliden

e-1,1-

diphosphonic 

acid)

21 CFR 

178.1010

Sulfuric acid

21 CFR 

184.1095

Octanoic acid

21 CFR 

184.1025

21 CFR 

182.1073

Phosphoric 

acid—cleaning of 

food-contact 

surfaces and 

TAP: Always combined with 

surfactant. Naphthalenesulfonic acid, 

sodium dodecylbenzene sulfonic acid, 

carboxylic acids, citric acid, lactic acid, 
Handling:OtherIngredients

equipment only. isopropyl alcohol, mention of FDA 

approved solutions, EDTA 

ethylenediaminetetraacetic acid 

21 CFR 

173.310

Cyclohexylamine 

(CAS # 108–91–

8)—for use only 

as a boiler water 

additive for 

packaging 

sterilization.

No "other ingredients"

21 CFR 

173.310

Diethylaminoeth

anol (CAS # 

100–37–8)—for 

use only as a 

boiler water 

additive for 

packaging 

sterilization.

No "other ingredients." Blended with 

sodium zeolite softened water.

21 CFR 

173.310

Octadecylamine 

(CAS # 124–30–

1)—for use only 

as a boiler water 

additive for 

packaging 

sterilization.

No "other ingredients"

Nutrient vitamins and 

minerals

Nutrient vitamin 

ingredients

21 CFR 

184.1930

Vitamin A No other ingredients mentioned in 

TAP

21 CFR 

184.1950

Vitamin D No other ingredients mentioned in 

TAP

USP/FCC Vitamin K1

(Phylloquinone) 

[required per 21 

CFR 107.100(c)]

No other ingredients mentioned in 

TAP

Vitamin K 

[Menaquinone-7 

]

No other ingredients mentioned in 

TAP

[GRN No. 245 

submitted & 

withdrawn]

21 CFR 

182.8890

Vitamin E 

[tocopherols]

No other ingredients mentioned in 

TAP

21 CFR 

182.8892

Vitamin E 

[alphatocopherol 

acetate]

No other ingredients mentioned in 

TAP

21 CFR Ascorbic acid No other ingredients mentioned in 
Handling:OtherIngredients

182.8013 TAP

21 CFR 

182.3189

Calcium 

ascorbate

No other ingredients mentioned in 

TAP

21 CFR 

182.3731

Sodium 

ascorbate

No other ingredients mentioned in 

TAP

21 CFR 

184.1875

Thiamine 

hydrochloride

No other ingredients mentioned in 

TAP

21 CFR 

184.1878

Thiamine 

mononitrate

No other ingredients mentioned in 

TAP

21 CFR 

184.1695

Riboflavin No other ingredients mentioned in 

TAP

21 CFR 

184.1697

Riboflavin-5'-

phosphate, 

sodium

No other ingredients mentioned in 

TAP

21 CFR 

184.1676

Pyridoxine 

hydrochloride

No other ingredients mentioned in 

TAP

21 CFR 

184.1945

Vitamin B12 No other ingredients mentioned in 

TAP

21 CFR 

184.1530

Niacin No other ingredients mentioned in 

TAP

21 CFR 

184.1535

Niacinamide No other ingredients mentioned in 

TAP

21 CFR 

172.345

Folic acid No other ingredients mentioned in 

TAP

21 CFR 

184.1212

Calcium 

pantothenate

No other ingredients mentioned in 

TAP

21 CFR 

182.8159

Biotin No other ingredients mentioned in 

TAP

21 CFR 

182.8890

Tocopherols—

derived from 

vegetable oil 

when rosemary 

extracts are not 

a suitable 

alternative.

No other ingredients mentioned in 

TAP

21 CFR ??? 

GRAS

Activated 

charcoal (CAS 

#s 7440–44–0; 

64365–11–3)—

only from 

vegetative 

sources; for use 

only as a filtering 

aid.

Pure carbon; no other ingredients

Alginates. Alginates are produced from alginic

acid and various alkaline elements 

(pH control agents). The pH control 

agents (are) ammonia, calcium 
Handling:OtherIngredients

hydroxide, potassium hydroxide, 

sodium hydroxide. No "other 

ingredients" mentioned.

21 CFR 

184.1133

Ammonium 

alginate

21 CFR 

184.1187

Calcium alginate

21 CFR 

184.1610

Potassium 

alginate

21 CFR 

184.1721

Sodium alginate

21 CFR 

184.1135

Ammonium 

bicarbonate—for 

use only as a 

leavening agent.

No TAP Review available; this 

substance is a single entity

21 CFR 

184.1137

Ammonium 

carbonate—for

use only as a 

leavening agent.

No TAP Review available; this 

substance is a single entity

21 CFR 

182.8013

Ascorbic acid. 1995 TAP: no "other ingredients"

21 CFR 

184.1195

Calcium citrate. 1995 TAP: no "other ingredients"

21 CFR 

184.1205

Calcium 

hydroxide.

1995 TAP: no "other ingredients"

21 CFR 

182.8217

Calcium 

phosphates 

(monobasic, 

dibasic, and 

tribasic).

1995 TAP: no "other ingredients"

21 CFR 

182.6215

Monobasic 

calcium 

phosphate

1995 TAP: no "other ingredients"

21 CFR 

182.1217

Dibasic calcium 

phosphate

1995 TAP: no "other ingredients"

21 CFR 

182.1217

Tribasic calcium 

phosphate

1995 TAP: no "other ingredients"

21 CFR 

184.1240

Carbon dioxide. 1995 & 2006 Tap: No "other 

ingredients"

21 CFR ??? 

GRAS

Cellulose—for 

use in 

regenerative 

casings, as an 

anti-caking agent 

(non-chlorine 

bleached) and 

filtering aid.

Petition: 100% cellulose (no "other 

ingredients"). 2001 TAP: "All additives 

must appear on the National List"
Handling:OtherIngredients

21 CFR 

184.

Ethylene—

allowed for 

postharvest 

ripening of 

tropical fruit and 

degreening of 

citrus.

No "other ingredients"

21 CFR 

184.1307

Ferrous sulfate—

for iron 

enrichment or 

fortification of 

foods when 

required by 

regulation or 

recommended 

(independent 

organization).

MSDS in TAP states composed of 

Iron II sulfate hydrate and sulfuric acid 

(2+) salt. No petition, or committee 

recommendation.

21 CFR 

184.1505

Glycerides 

(mono and di)—

for use only in 

drum drying of 

food.

None listed in TAP, or petition. No 

committee recommendation. 

21 CFR 

182.1320

Glycerin—

produced by 

hydrolysis of fats 

and oils.

No TAP, committee recommendation, 

or petition shown. 

21 CFR 

184.1425

Magnesium 

carbonate—

No" other ingredients" mentioned in 

TAP; but various grades mentioned

for use only in 

agricultural 

products 

labeled “made 

with organic 

(specified 

ingredients or 

food group(s))” 

21 CFR 

184.1426

Magnesium 

chloride—

derived from sea 

water.

No" other ingredients" mentioned in 

TAP

21 CFR 

184.1440

Magnesium 

stearate—

No" other ingredients" identified in 

TAP, but identified as a potential 

"incidental" additive itself in the TAP 

review

for use only in 

agricultural 

products 

labeled “made 

with organic 

(specified 

ingredients or 

food group(s))” 

21 CFR 

184.1595

Pectin (lowmethoxy).No "other ingredients" 
Handling:OtherIngredients

21 CFR 

184.1077

Potassium acid 

tartrate.

No "other ingredients" 

21 CFR 

184.1619

Potassium 

carbonate.

No "other ingredients" 

21 CFR 

184.1625

Potassium 

citrate.

1995 TAP: no "other ingredients"

21 CFR 

184.1631

Potassium 

hydroxide—

prohibited for 

use in lye 

peeling of fruits 

and vegetables 

except when 

used for peeling 

peaches during 

the Individually 

Quick Frozen 

(IQF) production 

process.

No "other ingredients" 

21 CFR 

184.1634

Potassium 

iodide—

No "other ingredients" for use only in 

agricultural 

products 

labeled “made 

with organic 

(specified 

ingredients or 

food group(s))” 

21 CFR 

184.

Potassium 

phosphate—

No "other ingredients" for use only in 

agricultural 

products 

labeled “made 

with organic 

(specific 

ingredients or 

food group(s))” 

21 CFR 

184.

Monobasic 

potassium 

phosphate

No "other ingredients" 

21 CFR 

182.6285

Dibasic 

potassium 

phosphate

No "other ingredients" 

21 CFR 

184.

Tribasic 

potassium 

phosphate

No "other ingredients" 

21 CFR 

172.480

Silicon dioxide. Petition: The 2010 petition to remove 

does not mention other ingredients. 

TR: The 1995 and 2010 TRs do not 

mention other ingredients.
Handling:OtherIngredients

21 CFR 

182.1087

Sodium acid 

pyro-phosphate 

(CAS # 7758–

16–9) –for use 

only as a 

leavening agent.

Petition: The 2002 petition and 2009 

petition to for expanded use do not 

mention other ingredients. TR: The 

2002 and 2010 TRs do not mention 

other ingredients.

21 CFR 

184.1751

Sodium citrate. TR: The 1995 TAP lists no other 

ingredients.

21 CFR 

184.1763

Sodium 

hydroxide—

prohibited for 

use in lye 

peeling of fruits 

and vegetables.

1995 TAP: No combinations listed. 

One reviewer states: "As with all 

synthetic inorganic salts, source must 

be food grade. In addition each lot 

should be analyzed for toxic elemnt 

concentrations (mercury, lead, 

cadmium, arsenic, thallium and 

antimony) and a near zero tolerance 

adpted.

21 CFR 

182.8778

Sodium 

phosphates—for 

use only in dairy 

foods.

Petition: The 2001 petition for sodium 

hexametaphosphate mentions other 

sodium phosphates. TR: The 2001 

TAP review states: Sodium 

phosphates are combined with 

calcium phosphates as leavening 

agents (Horsford, 1864; Ellinger, 

1972; FMC, no date). Sodium 

orthophosphates are often combined 

with insoluble sodium metaphosphate 

(IMP) and various polyphosphates 

(Ellinger, 1972; FMC, no date). The 

addition of other salts, such as sodium 

chloride, can have a synergistic effect 

on water-holding capacity (Gordon 

and Klimek, 2000). Typical 

commercial mixtures contain 30-60% 

soluble orthophosphates and 40-70% 

IMP (Gard, 1996). Starches are often 

used as carriers (Ashford, 1994). 

Trisodium phosphate used for 

cleaning is often combined with 

sodium hypochlorite (bleach) 

(Ashford, 1994). Sodium aluminum 

phosphate and sodium acid 

pyrophosphates are also used as a 

leavening agents (Food Chemicals 

Codex, 1996). The sodium 

phosphates are often used in 

combination with various gels such as 

agar, alginates, carageenan, pectins, 

and various gums (Ellinger, 1972). 
Handling:OtherIngredients

The previous sodium phosphates TAP 

Review (NOSB, 1995) only reviewed 

the forms mono-, di-, and tri-sodium 

phosphates. . This TAP Review does 

not cover other forms such as 

metaphosphates, pyrophosphates, 

polyphosphates, or combinations of 

sodium phosphates with any 

elemental constituents other than 

hydrogen. 

21 CFR 

182.3862

Sulfur dioxide—

for use only in 

wine labeled 

“made with 

organic grapes,”.

Petition: The 2010 petition does not 

mention other ingredients. TR: The 

1995 TAP does not mention 

combinations. The 2011 TR mentions 

citric acid and carbon dioxide, both of 

which appear on 205.605.

Provided, That, 

total sulfite 

concentration 

does not 

exceed 100 

ppm

21 CFR 

184.1099

Tartaric acid—

made from malic 

acid.

21 CFR 

182.6789

Tetrasodium 

pyrophosphate 

(CAS # 7722–

88–5)—for use 

only in meat 

analog products.

Petition not linked on the NOP 

website. The 2002 TAP review states: 

"Tetrasodium pyrophosphate is 

combined with calcium phosphates as 

leavening agents (Ellinger, 1972; 

FMC, no date). TSPP has a 

synergistic effect on various foaming 

agents, such as alkyl polycarboxylates 

and triethyl citrate (Sutton, 1960). 

Other salts, such as sodium chloride, 

can have a synergistic effect on waterholding capacity of sodium 

phosphates (Gordon and Klimek, 

2000)."

21 CFR 

172.695

Xanthan gum. 1995 TAP review by Steven Harper 

mentions that isopropyl alcohol is 

used to extract and purify xanthan 

gum and it is possible that trace 

amounts remain. FDA has limits for 

residual isopropyl.

7 CFR 205.606 Other Ingredients (TAP, TR, Petition, NOSB 

Recommendation)

a) Casings, from processed 

intestines.

No technical report requested. No other ingredients 

mentioned in the petition.

(b) Celery powder. The fresh celery is cleaned, concentrated by 

evaporation, heated and dried. There are no other 

chemicals or preserving agents used in the 

manufacture process.
Handling:OtherIngredients

(c) Chia ( Salvia hispanica L. 

).

Spanish sage. Petition: No other ingredients 

mentioned. No TR requested.

(d) Colors derived from 

agricultural products.

See specific colors as follows:

(1) Annatto extract color 

(pigment CAS # 1393–63–

1)—water and oil soluble.

NOSB recommended removal from the NL

(2) Beet juice extract color 

(pigment CAS # 7659–95–2).

Petition: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73."

(3) Beta-carotene extract 

color, derived from carrots or 

algae (CAS # 1393–63–1).

Petition: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73." 

"Beta-carotene and maltodextrin" in CWS powder. 

2009 Petition: "The main articles of commerce are 

suspensions in food grade vegetable oil or the liquids in 

oil made dispersable in water using food grade 

emulsifiers."

(4) Black currant juice color 

(pigment CAS #'s: 528–58–5, 

528–53–0, 643–84–5, 134–

01–0, 1429–30–7, and 134–

04–3).

Petition: ". . . contains only the natural constituents of 

the processed black currant. Citric acid and invert 

sugar may be used for standardization purposes and 

these ingredients are GRAS."

(5) Black/Purple carrot juice 

color (pigment CAS #'s: 528–

58–5, 528–53–0, 643–84–5, 

134–01–0, 1429–30–7, and 

134–04–3).

Petitions: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73." 

pH of flavor is less than 4.0; since carrots are a low-cid 

food, a food grade acid is being added (presumably 

citric acid).

(6) Blueberry juice color 

(pigment CAS #'s: 528–58–5, 

528–53–0, 643–84–5, 134–

01–0, 1429–30–7, and 134–

04–3).

Petition: "Citric acid and invert sugar may be used for 

standardization purposes and these ingredients are 

GRAS."

(7) Carrot juice color (pigment 

CAS # 1393–63–1).

Petition: "Citric acid and invert sugar may be used for 

standardization purposes and these ingredients are 

GRAS."

(8) Cherry juice color 

(pigment CAS #'s: 528–58–5, 

528–53–0, 643–84–5, 134–

01–0, 1429–30–7, and 134–

04–3).

Petition: "Citric acid and invert sugar may be used for 

standardization purposes and these ingredients are 

GRAS."

(9) Chokeberry—Aronia juice 

color (pigment CAS #'s: 528–

58–5, 528–53–0, 643–84–5, 

134–01–0, 1429–30–7, and 

Petitioner A: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73." 
Handling:OtherIngredients

134–04–3). Petitioner B: "Citric acid and invert sugar may be used 

for standardization purposes and these ingredients are 

GRAS."

(10) Elderberry juice color 

(pigment CAS #'s: 528–58–5, 

528–53–0, 643–84–5, 134–

01–0, 1429–30–7, and 134–

04–3).

Petition: "Citric acid and invert sugar may be used for 

standardization purposes and these ingredients are 

GRAS."

(11) Grape juice color 

(pigment CAS #'s: 528–58–5, 

528–53–0, 643–84–5, 134–

01–0, 1429–30–7, and 134–

04–3).

Petition: "Citric acid and invert sugar may be used for 

standardization purposes and these ingredients are 

GRAS."

(12) Grape skin extract color 

(pigment CAS #'s: 528–58–5, 

528–53–0, 643–84–5, 134–

01–0, 1429–30–7, and 134–

04–3).

Petition: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73."

(13) Paprika color (CAS # 

68917–78–2)—dried, and oil 

extracted.

Petition: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73." 

NOSB: "Organic Oil must be used for the oil 

extraction."

(14) Pumpkin juice color 

(pigment CAS # 127–40–2).

Petition: "Citric acid and invert sugar may be used for 

standardization purposes and these ingredients are 

GRAS."

(15) Purple potato juice 

(pigment CAS #'s: 528–58–5, 

528–53–0, 643–84–5, 134–

01–0, 1429–30–7, and 134–

04–3).

Petition: "Citric acid and invert sugar may be used for 

standardization purposes and these ingredients are 

GRAS."

(16) Red cabbage extract 

color (pigment CAS #'s: 528–

58–5, 528–53–0, 643–84–5, 

134–01–0, 1429–30–7, and 

134–04–3).

Petitioner A: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73." 

Petitioner B: "Citric acid and invert sugar may be used 

for standardization purposes and these ingredients are 

GRAS."

(17) Red radish extract color 

(pigment CAS #'s: 528–58–5, 

528–53–0, 643–84–5, 134–

01–0, 1429–30–7, and 134–

04–3).

Petition: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73."

(18) Saffron extract color 

(pigment CAS # 1393–63–1).

Petition: "Specific formulation is withheld as a trade 

secret pursuant to 21CFR20.61. The characterizing 

principles and/or other components of this color blend 

are approved and are in compliance with 21CFR73."

(19) Turmeric extract color 2007 Petition: "Specific formulation is withheld as a 
Handling:OtherIngredients

(CAS # 458–37–7). trade secret pursuant to 21CFR20.61. The 

characterizing principles and/or other components of 

this color blend are approved and are in compliance 

with 21CFR73."

(e) Dillweed oil (CAS # 8006–

75–5).

No "other ingredients."

(f) Fish oil (Fatty acid CAS 

#'s: 10417–94–4, and 25167–

62–8)—stabilized with organic 

ingredients or only with 

ingredients on the National 

List, §§205.605 and 205.606.

None of the other ingredients are disclosed in the 

Petition.

(g) Fortified cooking wines.

(1) Marsala. No sulfites; grapes and yeast fermented, salt added, 

bentonite filtered.

(2) Sherry. No sulfites; grapes and yeast fermented, salt added, 

bentonite added, filtered with diatomaceous earth.

(h) Fructooligosaccharides

(CAS # 308066–66–2).

Sucrose is converted by a fermentation reaction to 

short-chain molecules containing two, three, or four 

fructose units. No “other ingredients.”

(i) Galangal, frozen.

(j) Gelatin (CAS # 9000–70–

8).

Specifically states in TAP that it is often combined with 

other ingredients and each of these other ingredients 

would need to appear on the NL or be organic. 

Isinglass (made from fish bladders) can contain tartaric 

acid to balance pH as a preservative. Metabisulfite as a 

stabilizer. Bentonite for juice clarification. Sucrose 

added to increase set time. Capsules use hardening 

agents like glycerine, various alcohols, propylene 

glycol, sucrose and acacia. Starches for secondary as 

disintegrants. Formaldehyde and glutaraaldehyde used 

as hardening agents for encapsulation of flavors. 

Surfactants such as polysorbates used for increased 

dispersion. Substances considered GRAS for use in 

geletin capsules succinylated gelatin, arabinogalactan, 

silicon dioxide, glutataldehyde, n-Octyl alcohol, 

petroleum wax, polyacrylamide, and terpine resin.

(k) Gums—water extracted 

only (Arabic; Guar; Locust 

bean; and Carob bean).

None shown in TAP. No petition, or committee 

recommendation.

Gum Arabic

Guar Gum

Locust bean gum

Carol bean gum

(l) Hops ( Humulus luplus ).

(m) Inulin-oligofructose 

enriched (CAS # 9005–80–5).

Kafir Lime Leaves None shown in petition, committee proposal, or formal 
Handling:OtherIngredients

recommendation. No TAP.

(n) Kelp—for use only as a 

thickener and dietary 

supplement.

None shown in TAP. No committee recomendationm, 

or petition. 

(o) Konjac flour (CAS # 

37220–17–0).

No petition, TAP, or committee recommendation. 

(p) Lecithin—de-oiled. No" other ingredients"

(q) Lemongrass—frozen. No" other ingredients"

(r) Orange pulp, dried. No" other ingredients"

(s) Orange shellacunbleached (CAS # 9000–

59–3).

No information available on NOP website

(t) Pectin (high-methoxy).* TAP on NOP website is for low-methoxy pectin; No 

"other ingredients" mentioned

(u) Peppers (Chipotle chile). No" other ingredients"

(v) Seaweed, Pacific kombu.

(w) Starches.

(1) Cornstarch (native). No "other ingredients"

(2) Rice starch, unmodified 

(CAS # 977000–08–0)—for 

use in organic handling until 

June 21, 2009.

Petition: "Rice starch interacts with the other thickening 

agents to create a unique gelation agent. The 

combination of rice starch, locust bean gum, pectin, 

and carrageenen reinforce the gels of each component, 

provide an elastic texture and prevents syneresis 

separation of water). " No TR requested.

(c) Chia ( Salvia hispanica L. 

).

Spanish sage. Petition: No other ingredients 

mentioned. No TR requested.

(3) Sweet potato starch—for 

bean thread production only.

Petition: Is not linked on the NOP's website. No TR 

requested.

(x) Tragacanth gum (CAS #–

9000–65–1).

Petition: The 2007 petition mentions other gums on 

606. TR: The 1995 TAP review lists no combinations. 

No TR requested for the 2007 petition.

(y) Turkish bay leaves. Petition: The 2006 petition does not mention other 

ingredients. No TR requested.

(z) Wakame seaweed 

(Undaria pinnatifida).

(aa) Whey protein 

concentrate.

No other ingredients mentioned in petition or 

recommendation

*Specification sheets often indicate pectin is standardized with sugar